Relmada (RLMD) Q3 2026 Earnings Call Transcript

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DATE

Nov. 12, 2026

CALL PARTICIPANTS

• Chief Executive Officer - Sergio Traversa
• Chief Business Officer - Bipin Dalmia
• Chief Financial Officer - Maged Shenouda

TAKEAWAYS

• Cash and Short-term Investments -- $202.1 million as of Sept. 30, 2026, compared to approximately $93.0 million at the end of 2025.
• Cash Runway -- through 2029, which management stated is sufficient to complete the registrational Phase 3 SPECTRUM studies for NDV-01.
• Research and Development Expense -- $9.2 million for the third quarter, compared to $4.0 million in the prior year, reflecting higher study preparation costs and manufacturing storage.
• General and Administrative Expense -- $3.9 million, down from $6.3 million due to lower stock-based compensation and reduced stock appreciation rights expenses.
• Net Loss -- $13.9 million, or $0.12 per basic and diluted share, for the three months ended Sept. 30, 2026.
• Phase 2 Complete Response Rate at 18 Months -- 86%, with 12 of 14 evaluable patients who reached the 18-month mark remaining in complete response.
• Phase 2 BCG-Unresponsive Complete Response Rate at 18 Months -- 88%, representing seven of eight evaluable patients in this high-risk subgroup.
• Phase 2 Anytime Complete Response Rate -- 94% across a dataset of 51 evaluable patients, with a 96% rate specifically in the BCG-unresponsive subgroup.
• Phase 2 12-Month Complete Response Rate -- 77% in the overall high-risk population and 73% in the BCG-unresponsive subgroup.
• Treatment-Related Adverse Events -- zero occurrences of Grade 3 or higher events, serious adverse events, or discontinuations in the Phase 2 study to date.
• Phase 2 Survival Metrics -- 100% for both progression-free and cystectomy-free survival through 12 months.
• Shares Outstanding -- 106,694,846 as of Nov. 10, 2026.
• Net Cash Used in Operating Activities -- $12.6 million for the three months ended Sept. 30, 2026, compared to $6.7 million for the same period in 2025.
• Investigational New Drug Submissions -- management expects to submit applications for both NDV-01 and sepranolone by year-end 2026.
• Phase 3 Enrollment Timeline -- management expects to enroll the first patient in the first quarter of 2027, assuming an Investigational New Drug clearance period of 30 to 45 days.
• Interest and Investment Income -- $2.3 million for the third quarter, compared to $247,013 in the same period last year.
• Total Assets -- $205.3 million as of Sept. 30, 2026, including approximately $205.0 million in current assets.
• Total Current Liabilities -- $7.8 million as of Sept. 30, 2026, compared to $6.4 million at the end of 2025.

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RISKS

• Dalmia stated, "Two patients progressed to muscle-invasive disease at month 15, 1 BCG-naive T1 patient, and a second BCG-naive CIS with T1 patient," noting that these recurrences occurred after the patients had been responders through 12 months.

SUMMARY

Relmada Therapeutics, Inc. (NASDAQ:RLMD) reported significant clinical and operational progress focused on its lead oncology and central nervous system candidates, NDV-01 and sepranolone. Management highlighted the continued durability of response in the Phase 2 study for NDV-01, which has supported the design of the renamed Phase 3 SPECTRUM program. The company stated that its current capital position provides a multiyear runway to fund these registrational trials and secondary programs. Operational efforts are currently concentrated on finalizing manufacturing stability data to support two Investigational New Drug submissions before the end of 2026.

• Management renamed the Phase 3 program SPECTRUM, formerly RESCUE, to highlight the potential utility of NDV-01 across the entire non-muscle invasive bladder cancer disease range.
• CEO Traversa noted that the manufacturing process is an optimization of an original hospital pharmacy prototype and confirmed the company is currently generating stability data from two manufacturing efforts in the U.S. and Israel.
• The company is finalizing stability testing for the sepranolone pre-filled syringe delivery system to support a planned Phase 2 proof-of-concept study in Prader-Willi syndrome.
• Dalmia indicated that the Phase 3 SPECTRUM program will allow re-induction only at the three-month mark, a protocol established through alignment with the FDA.
• The SPECTRUM program includes two independent pathways: a single-arm study for second-line BCG-unresponsive patients and a randomized study for low-grade intermediate-risk adjuvant therapy.
• Management reported that 100% of patients in the Phase 2 study have avoided radical cystectomy to date, emphasizing the potential for NDV-01 as a bladder-sparing alternative.

INDUSTRY GLOSSARY

• BCG-Unresponsive: Bladder cancer that fails to respond to treatment with Bacillus Calmette-Guerin, the standard-of-care immunotherapy.
• CIS (Carcinoma in Situ): A high-grade, non-invasive form of bladder cancer that appears as a flat tumor on the bladder lining.
• GABAA Receptors: A class of receptors that respond to the neurotransmitter gamma-aminobutyric acid, which sepranolone is designed to modulate.
• IND (Investigational New Drug): An application submitted to the FDA to seek permission to start human clinical trials.
• NDV-01: Relmada's sustained-release co-formulation of the chemotherapy drugs gemcitabine and docetaxel.
• NMIBC: Non-muscle invasive bladder cancer, a stage of cancer found in the inner layers of the bladder that has not yet spread into the muscle.
• Sepranolone: A neurosteroid epimer being developed for central nervous system disorders related to excessive GABAergic activity.
• TURBT: Transurethral resection of bladder tumor, a surgical procedure used to diagnose and treat bladder cancer.

Full Conference Call Transcript

Operator: Good afternoon and welcome to the Relmada Therapeutics third quarterearnings conference call [Operator Instructions] As a reminder, this conference call is being recorded and will be available for replay on the Relmada website. I would now like to turn the call over to Brian Ritchie from LifeSci Advisors. Please go ahead, Mr. Ritchie.

Brian Ritchie: Good day, everyone, and thank you for joining us today. This afternoon, Relmada issued a press release providing a business update and outlining its financial results for the 3 and 9 months ended September 30, 2026. Please note that certain information discussed on the call today is covered under the safe harbor provision of the Private Securities Litigation Reform Act. Relmada's management team will be making forward-looking statements during this call. Actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business.

These forward-looking statements are qualified by the cautionary statements contained in Relmada's press release issued today and the company's SEC filings, including the company's 10-Q filing for the quarter ended September 30, 2026, filed after the close today. This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast on November 12, 2026. Relmada undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call. With me today on today's call are Relmada's CEO, Dr. Sergio Traversa; Dr. Bipin Dalmia, Relmada's Chief Business Officer; and Relmada's CFO, Maged Shenouda.

After the prepared remarks, we will open the call for a brief Q&A session. Now, I would like to hand the call over to Sergio Traversa. Sergio?

Sergio Traversa: Thank you, Brian. Good afternoon, everyone, and welcome to the Relmada Third Quarter 2026 Conference Call. We have made significant progress with the NDV-01 program in the third quarter, and during today's call, I will provide the business overview, including an update on manufacturing. Bipin will review the 18-month Phase 2 results, which continue to demonstrate durability of response and a favorable safety profile, as well as the Phase 3 registration program, now renamed SPECTRUM, to reflect NDV-01's potential across the full spectrum of non-muscle-invasive bladder cancer, NMIBC. Maged will then review the third quarter financial results, and then I will come back to make a few concluding remarks. Let's start with NDV-01.

NDV-01 is a novel, sustained-release intravesical formulation that combines gemcitabine and docetaxel with the potential for quick and convenient administration in the urology office. In the quarter, we have made significant progress in the manufacturing process, and we are on track to submit the IND by year-end 2026. The IND clearance will allow us to begin our registrational trials, making -- marking an important step forward in the approval process for NDV-01. Beyond the IND filings, we have established a manufacturing plan to provide uninterrupted clinical supply through Phase 3 and support commercial readiness.

Regarding sepranolone, our program for Prader-Willi syndrome, we are finalizing the stability testing of our pre-filled syringe to enable IND submission, which is anticipated by year-end 2026, and we expect to begin the Phase 2 proof-of-concept study upon IND clearance. I will now give Bipin the privilege to take you through the 18-month data and the Phase 3 program for NDV-01.

Brian Ritchie: Thank you, Sergio, and good afternoon, everyone. For bladder-sparing therapies in non-muscle-invasive bladder cancer, or NMIBC, patients and physicians are still forced to trade off efficacy, durability, tolerability, and convenience. We believe NDV-01 has the potential to deliver on all those dimensions simultaneously, and importantly, with a ready-to-use product that is designed for ease of market adoption and broad utilization. The data we are reporting today reinforce that view. Let me start with the initial 18-month Phase 2 results for NDV-01. In NMIBC, durability of response is a key question, and our long-term extension is where it gets answered. Twenty-three high-risk NMIBC patients who were in complete response, or CR, at 12 months continued into a long-term extension study.

Of the 14 evaluable patients at 18 months, 12 or 86%, remain in CR. In the BCG-unresponsive subgroup, 7 of 8 patients or 88%, remain in CR at 18 months. Two patients progressed to muscle-invasive disease at month 15, 1 BCG-naive T1 patient, and a second BCG-naive CIS with T1 patient. No patients in the study have undergone a radical cystectomy to-date. We also updated our 12-month results, which now include 51 high-risk NMIBC patients. As the dataset has grown, the results have remained consistent, with an anytime CR rate of 94% and a 12-month CR rate of 77%.

In the BCG-unresponsive subgroup, where the need for refractory bladder-sparing options is the greatest, the anytime CR rate was 96%, and the 12-month CR rate was 73%. Just as important, these efficacy results come with a consistently favorable safety and tolerability profile. In the Phase 2 study to-date, there have been no Grade 3 or higher treatment-related adverse events, no treatment-related serious adverse events, and no treatment-related discontinuations. Our market research shows that for a therapy designed for repeated in-office administration, including in the community setting where most patients are treated, such a clean safety and tolerability profile matters. Turning to our registrational Phase 3 program.

As Sergio noted, we have renamed it SPECTRUM to reflect the potential breadth of NDV-01 across the entire NMIBC disease spectrum. Importantly, the program itself remains unchanged, with two FDA-aligned independent registration pathways. The first is a single-arm registration study in second-line, high-risk BCG-unresponsive NMIBC patients with carcinoma in situ, or CIS, with or without papillary disease. In addition, we have a separate exploratory cohort in second-line, high-risk BCG-unresponsive papillary-only disease. The second is a randomized study of NDV-01 as adjuvant therapy following TURBT versus observation in low-grade intermediate-risk NMIBC, a setting with no approved therapy currently.

To sum up, we believe the larger and more mature Phase 2 data continue to support NDV-01's potential to uniquely combine high and durable responses, a favorable safety and tolerability profile, with a simple in-office administration of a ready-to-use sustained-release biodegradable product, the combination physicians tell us they need. We look forward to initiating the Phase 3 SPECTRUM program upon IND clearance. With that, I will turn the call over to Maged. Maged?

Maged Shenouda: Thanks, Bipin, and good afternoon, everyone. I'd like to build on Sergio and Bipin's comments by highlighting the substantial progress in manufacturing that should enable us to file the INDs for NDV-01 and sepranolone by year-end. We're also encouraged by the continued durability of response of the 18-month data that positions NDV-01 competitively and has the potential to make a meaningful difference in patient lives. I'll now walk you through our third quarter 2026 financial results. Our press release and 10-Q filing provide the full details, including the 9-month results. Relmada closed the third quarter of 2026 with cash, cash equivalents, and short-term investments of $202.1 million, compared to $93 million at December 31, 2025.

Our current cash position is expected to fund company operations through 2029, including completion of the registrational Phase 3 NDV-01 SPECTRUM studies. Moving briefly through our third quarter financial results. Research and development expense for the 3 months ended September 30, 2026 totaled $9.2 million compared to $4 million for the 3 months ended September 30, 2025. The increase was primarily attributable to higher NDV-01 and sepranolone study preparation costs, increased manufacturing drug storage costs, and higher employee compensation, partially offset by lower stock-based compensation. General and administrative expense for the same period totaled $3.9 million, compared to $6.3 million for the same period last year.

The decrease was primarily driven by lower stock-based compensation and lower stock appreciation rights expense, partially offset by higher employee compensation and consulting services. Net cash used in operating activities for the 3 months ended September 30, 2026 totaled $12.6 million compared to $6.7 million for the 3 months ended September 30, 2025. The net loss for the quarter was $13.9 million or $0.12 per basic and diluted share compared with a net loss of $10.1 million or $0.30 per basic and diluted share for the third quarter of 2025. Before we open the call for questions, I'll turn it back to Sergio for some closing comments. Sergio?

Sergio Traversa: Thank you, Maged. Before we open to the Q&A, I would like to summarize the significant progress Relmada made in the third quarter with NDV-01 and sepranolone. We made important advancements with NDV-01 manufacturing, and we continue to expect to submit the IND for NDV-01 by year-end 2026 and initiate the Phase 3 SPECTRUM program upon IND clearance. The 18-month Phase 2 results provide further evidence of durable responses with NDV-01. We believe these findings strengthen NDV-01's potential to make a meaningful difference for patients with NMIBC. For sepranolone, we also continue to expect to file the IND by year-end 2026.

Importantly, our cash resources are expected to fund operations through 2029, including the completion of the registrational Phase 3 SPECTRUM studies. I want to thank our team and our manufacturing partners for their dedication. I'm also grateful to the patients and investigators who made the NDV-01 Phase 2 study possible and to our shareholders for their continued support. We look forward to keeping you updated as we work to bring NDV-01 and sepranolone closer to patients. Operator, we can now open to -- the call for questions.

Operator: [Operator Instructions] Our first question comes from Kelsey Goodwin with Piper Sandler. Please go ahead.

Kelsey Goodwin: Congrats on the update. Great to see. In terms of that data set, maybe could you just remind us the split of CIS and papillary here? I know we get a lot of questions on this from investors, and maybe how to compare this dataset to competitors given the CIS to papillary split. And then, second, in terms of the IND for NDV-01, maybe just remind us what still needs to be done before we get that fully filed by the end of the year.

Sergio Traversa: Hi, Kelsey. It's Sergio here. I'll let Bipin answer the CIS question, then maybe I'll take the manufacturing question. Bipin, would you mind?

Brian Ritchie: Yes. Hi, Kelsey. We had a mix of CIS with pure CIS, CIS Ta, and CIS with T1 patients. We look forward to sharing additional results as the dataset matures and believe a future medical meeting may be a more appropriate forum to provide further details on the CIS subgroup.

Sergio Traversa: And look, for the manufacturing, I wouldn't like to go too much into details because it gets very complicated, but the -- for the -- we are writing the IND as we are speaking and definitely planning to complete all write-ups and all filings before year-end. And we are waiting for stability data. And we have significant stability data already, and they look good. We have two efforts: the U.S. effort with Piramal and the Israeli effort with Scinai. And so far, both sets of stability data look good.

We haven't decided how we will move forward, but I would say it's a nice problem to have, and it looks like we'll have both products will meet the FDA requirements for the IND. So it's a work in progress. Hope I answered your question.

Kelsey Goodwin: Congrats again.

Operator: Your next question comes from Andres Maldonado with H.C. Wainwright. Please go ahead.

Andres Maldonado: Congrats on the progress. A couple quick ones from me. Just reading into the press release, the first one is, both patients who progressed to muscle-invasive disease, since they entered with T1 disease, the question is, were there earlier warning signs, and does that change how you would select or monitor for these T1 patients coming up? And if you can remind us or if you can just give us a little bit more color on how many patients in the Phase 2 actually match the second-line SPECTRUM population? Having failed another treatment after BCG, and kind of if you can give us additional color on what that efficacy in that subset looks like?

Sergio Traversa: I believe Bipin can answer this question. Bipin?

Brian Ritchie: Yes. For the two patients who progressed, both of them were BCG-naive patients, as noted in the press release. The first patient was the T1 patient that received repeat TURBT before study entry and was a responder through, I believe, 9 months and -- through 12 months, and then continued into the study, and the recurrence with T2a disease happened at 15 months. So there were no early warning signs to answer your question. And a very similar situation with patient number 2.

That patient was also a T1 patient with CIS at study entry, was a responder through 12 months, continued through into the extension portion of the study, and then recurred once again with T2 disease at 15 months. Importantly, these patients, after the 12-month CR, did not comply fully with their maintenance dosing between months 12 and 15. So that could have been 1 factor, we don't know. But that's the level of detail we have on those two patients.

Sergio Traversa: Okay. Great, thank you. There was a second question too, Bipin.

Brian Ritchie: I'm sorry, Andres, can you please remind me of the second question?

Andres Maldonado: Sure, absolutely. So the question is, just looking at how many patients actually match the second-line SPECTRUM population, having failed another treatment after BCG, what does efficacy look like in that subset for the Phase 2 patients? Just trying to reconcile patient subsets to see if we can get a little bit of further detail on efficacy over time here that match the SPECTRUM population.

Brian Ritchie: Yes, yes, yes. So we have not conducted that analysis. I would like to note that the Phase 2 study is being conducted in Israel, where most of the first-line treatments were not available until very recently. I think 1 of the products has been launched very recently. So the only time they could have achieved treatment other than BCG would have been after off-label chemo, and we have not conducted that analysis yet.

Operator: Your next question comes from Farzin Haque with Jefferies. Please go ahead.

Farzin Haque: Congrats on the progress. Just tacking back on the CMC, can you clarify if the issues have been completely resolved and you're simply waiting for the stability data, and if the early spec releases were all in line with your expectations? And then I have a follow-up.

Sergio Traversa: Yes, sure. Well, I would not define that there was really some specific issue that needed to be resolved. As I mentioned in other calls, right, this 1 was not a technology transfer. So with the product manufactured in another country or location and transferred to a different plant, this was the original product that is used in Phase 2. It's literally a prototype made in the pharmacy of the hospital and used in a very short amount of time, and is sterilized with an autoclave that is heating up to 120 degrees Celsius the product. Clearly, that process of manufacturing is not suitable for scaling up and for an IND filing.

So we had to recreate from the starting point a brand-new process and to manufacture exactly the same product. And as you may imagine, manufacturing is a process that takes time. And so like we had, yes, at least 1 attempt to design a process that worked but was not ideal. So we modified the old -- the process, and now we have 2 processes different to sterilize the product in place.

And the -- all the steps have been optimized, and now the production is -- we did GMP batches and it looks like, at least from the initial -- and not really initial, I believe we have a 9 weeks stability, it looks like it's well within the FDA requirements for the stability of the product. So I hope I answered right. There was no real particular issue that needed to be resolved. It was the process that needed to be optimized, and it looks like now it's in the right direction.

Farzin Haque: Thank you for the color. And then for Bipin, maybe for Phase 2, do you have the updated swimmers' plot for all patients? How many of them required re-induction since the last cut? Hello?

Operator: Your line is open.

Brian Ritchie: Okay. Sorry. So we've provided some re-induction information in our updated corporate deck. So in the overall population, we had 6 patients who were re-induced at 3 months in the overall population, and 3 of them converted from a non-CR at 3 months to a CR at 6 months. And the study allowed for re-induction at any time during the first 12 months. So there were some additional re-inductions, and that data we will provide at a future medical congress. But the more important point is in our Phase 3 going forward, we will allow re-induction only at the 3-month study as agreed with the FDA.

Operator: [Operator Instructions] Your next question comes from Andrew Berens with Leerink. Please go ahead.

Unknown Analyst: Hi, this is [ Troy ] on for Andy. With the IND filing expected by year-end, how quickly do you think you can get from IND clearance to first patient dose?

Sergio Traversa: We'll run it quickly because we had several months where we evaluated various sites and they all -- there's been significant progress in the signing the contract, and clearly we need an IND clearance before the IRB can actually approve the product. But if you like, if you want a really give number, I would say if the IND gets cleared in a reasonable amount of time, that can be 30, 45 days, including the holidays in between, we should be able to enroll the first patient within the first quarter of next year.

Operator: There are no further questions at this time. I would like to turn the call back over to Sergio Traversa for closing remarks.

Sergio Traversa: Thank you, and a big thank you to everyone for the interest in our story. And we look forward to an update at the next conference call next quarter. Thank you very much.

Operator: Ladies and gentlemen, this concludes today's conference call. We thank you for participation. You may now disconnect.

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